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. 2024 May 10;14(5):e078114. doi: 10.1136/bmjopen-2023-078114

Table 1.

Overview of the primary and secondary outcomes and the assessment method at each time interval

Outcome Method A1
Baseline
A2, 3, 4
1, 3, 6 months
A5
12 months
A6
18 months
A7
24 months
A8
36 months
Primary outcome
 Lymphoedema-specific QoL Lymphoedema Functiong, Disability and Health (Lymph-ICF) questionnaire for upper or lower limb lymphoedema13 19 20 27 X X
Secondary outcomes
Self-reported questionnaire
 Lymphoedema-specific QoL See primary outcome X X X X X
 Duration (key secondary outcome) and experience of wearing compression garment Compression questionnaire developed by the International Compression Club (or ICC compression questionnaire)28 X X X X X X
 Health-related QoL EuroQol-5D-5L which is a health status measure developed by the EuroQol group containing 5 dimensions and 5 levels29 X X X X X X
 Work capacity and ability Work Productivity and Activity Impairment questionnaire30; QuickScan 1831 X X X X X X
 Physical activity level International Physical Activity Questionnaire32 X X X X X X
 Costs related to lymphoedema and its treatment* Study-specific questionnaire X X X X X
 Usual care and self-management*†, including need for intensive treatment Study-specific questionnaire X X X X X
Assessments
 Limb volume (key secondary outcome) Circumference measurements every 4 cm with perimeter16 33–35 X X X X X X
 Hand/foot volume Water displacement method of hand or foot34 36 X X X X X X
 Failure to reduce hours a day of wearing compression garment Based on change in limb volume X X X X
 Body weight Scale X X X X X X
 Infection previous 18 months Interview X X X
 Recurrence of cancer Interview and medical file X X
 Adverse events and complications of surgery Interview and medical file X X X X X
Lymphatic transport Lymphofluoroscopy using Indocyanine Green (or ICG fluoroscopy)37; lymphoscintigraphy38 39 X X

*Information is collected on a monthly basis.

†No secondary outcome.

QoL, quality of life.